UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058437 |
|---|---|
| Receipt number | R000066819 |
| Scientific Title | Evaluation of the Usefulness of Intraoral Pressure Measurement Using IOP-01 for Respiratory Muscle Strength Assessment Before and After Pulmonary Resection |
| Date of disclosure of the study information | 2025/07/14 |
| Last modified on | 2025/07/12 07:17:20 |
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Basic information
Public title
Evaluation of the Usefulness of Intraoral Pressure Measurement Using IOP-01 for Respiratory Muscle Strength Assessment Before and After Pulmonary Resection
Acronym
IOP-LUNG Study
Scientific Title
Evaluation of the Usefulness of Intraoral Pressure Measurement Using IOP-01 for Respiratory Muscle Strength Assessment Before and After Pulmonary Resection
Scientific Title:Acronym
IOP-LUNG Study
Region
| Japan |
Condition
Condition
primary lung cancer, metastatic lung nodules
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively evaluate changes in respiratory muscle strength before and after pulmonary resection using the IOP-01 device (Kobata Gauge MFG Co., Ltd.), and to clarify its validity and clinical usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoral pressure measurements at preoperative, 1-month postoperative, and 3-month postoperative time points.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo pulmonary resection for primary lung cancer (or suspected cases) or metastatic lung tumors (or suspected cases)
Patients aged 20 years or older at the time of consent
Patients who have provided written informed consent to participate in the study
Key exclusion criteria
Patients deemed inappropriate for participation by the principal investigator or co-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shintani |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
565-0871
Address
2-2 (L5), Yamadaoka, Suita-city, Osaka
TEL
06-6879-3152
yshintani@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kimura |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
565-0871
Address
2-2 (L5), Yamadaoka, Suita-city, Osaka
TEL
06-6879-3152
Homepage URL
kimura@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066819
